In general, implantable medical devices are commonly used with medical electrical leads. Medical leads deliver electrical energy for stimulation of tissue, receive sensed electrical impulses from tissue, or transfer other sensory data indicative of a physical parameter. For example, implantable cardiac pacemakers, cardioverters, or defibrillators commonly have one or more leads connecting the device to cardiac tissue. The leads are typically inserted through a vein and guided into the target location of the cardiac tissue. Once so located, the distal end of the lead is typically affixed to the tissue to secure the lead in the desired location.
Maintaining a sterile field around the incision site is especially important during the implantation procedure. The sterile field prevents contamination that may otherwise occur due to unsanitary conditions. Contamination of the surgical incision site during the implant procedure can lead to pocket infection (infection of the incision site) which may propagate to the cardiac tissue. Therefore, numerous steps are taken during the implant procedure to minimize or prevent the risk of contamination of the surgical incision site. In addition to providing a sterile field around the incision site, all the instruments, tools and equipment that come in contact with the sterile field during the implant procedure are sterilized prior to use and re-sterilized if any contamination is suspected.
Generally, the lead implant procedure may be thought of as a two-phase process. The first involves the placement of the lead in the target tissue while the second phase involves verification of the implanted lead's functionality and determining whether the placement location is appropriate or if there is a need to reposition the lead. This verification is typically performed though testing performed via a programmer. The programmer used can be a fully functional programmer, such as MEDTRONIC MODEL 9790 ®, or a task specific programmer, such as a pacing system analyzer. In the first phase, a lead is passed through a vein into the desired tissue location and secured to the tissue. Following the placement of the distal end of the lead in the target tissue, a programmer is attached to the proximal end of the lead and various parameters are checked to verify the functionality and whether the lead implant location is appropriate. Thereafter the implantable medical device is connected to the lead and the incision site is closed thereby sealing the implantable medical device and lead within the patient's body.
As the foregoing discussion of the implant procedure demonstrates, the need to re-position the distal end of the lead is typically discovered during the second phase and after much time has been expended placing the lead in the first phase. Moreover, the programmer is located outside the sterile field and is connected to the leads using a set of cables.
The programmer cables therefore have to be sterilized and care taken to ensure that they remain within the sterile field during the implant procedure to prevent contamination of the incision site. Furthermore, the process of re-positioning the lead to an optimal location requires that the programmer cable be disconnected from the lead to allow for the lead to be navigated to the new location in the tissue. As such, many implant procedures may be cumbersome and time consuming.